Protocol Number: 82-I-0183

Title:

Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut

Number:

82-I-0183

Summary:

This study will investigate in patients with Crohn's disease and ulcerative colitis how the body's immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments.

Patients between the ages of 8 and 75 years of age with Crohn's disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may include the following: medical history and physical examination, routine blood tests, examination of stool specimens, X-rays such as barium enema or upper GI series, proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.

Participants will receive medical treatment according to the best generally accepted measures for treating Crohn's disease or ulcerative colitis. This may include anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be recommended for patients whose disease does not respond to medical treatment. If surgery to remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform the procedure.

In addition, participants may undergo the following procedures:

- Blood drawing - No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will be taken from adults over a 6-week period. A maximum of 7 ml (1/2 tablespoon) of blood per kilogram (2.2. pounds) of body weight will be obtained from children within the same time period, with no more than 3 ml/kg taken at any one time.

- Leukapheresis - This procedure is done to collect large quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is circulated through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.

- Intestinal biopsies - Intestinal tissue will be obtained during colonoscopy with intestinal biopsy in patients who require this procedure as part of their standard medical care. Patients are given a sedative to reduce anxiety, but are conscious during the procedure. A flexible tube is inserted into the rectum and large intestine, allowing the physician to see the intestinal mucosa. At various places, small pieces of tissue are plucked out.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

1. Patients with verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition and which is supported by characteristic features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes;

OR

2. Patients with clinical features consistent with an unclassified bowel disease and histologic evidence of inflammation of the intestine;

OR

3. Patients with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), including but not limited to abdominal pain, fistulae, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms (pyoderma, erythema nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified;

OR

4. Patients who have a defined genetic syndrome linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD.

5. All subjects to be enrolled will be age 8 through 75 (but greater than or equal to 18 years old for Hermansky-Pudlak syndrome patients).

6. To participate in the research biopsies during endoscopy, subjects must have the following lab values within two weeks of the procedure:

Hematocrit greater than or equal to 30%

Platelet count greater than 100,000

PT INR less than or equal to 1.3 or PTT prolonged by less than 3 seconds

EXCLUSION CRITERIA:

1. Failure to meet the inclusion criteria.

2. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject.

NOTE: Pregnant patients are not excluded from enrolling in this natural history protocol, but they are excluded from research procedures such as pheresis, more than 100 ml venipuncture volumes within 6 weeks, and research endoscopies. However, they are eligible for and tests or procedures that are medically-indicated and can be done with minimal risk to the fetus.

Special Instructions:

Currently Not Provided

Keywords:

Inflammatory Bowel Disease

Regional Enteritis

Crohn's Disease

Ulcerative Colitis

Recruitment Keyword(s):

Ulcerative Colitis

Inflammatory Bowel Disease

IBD

Condition(s):

Crohn's Disease

Inflammatory Bowel Disease

Ulcerative Colitis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

The immunopathogenesis of gastrointestinal and hepatobiliary diseases

Increased interleukin-2 messenger RNA in the intestinal mucosal lesions of Crohn's disease but not ulcerative colitis

Antibodies to IL-12 abrogate established experimental colitis in mice

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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